Endpoint Adjudication: the Race Against Time

By Dimitri Stamatiadis 12 Nov, 2018

Clinical Event Adjudication: The Race Against Time

Processing endpoint adjudication data in a timely fashion is paramount to the good conduct of a clinical trial. Professionalism and dedication alone cannot do it without the help of the appropriate technology.

Endpoint adjudication (EA) by an independent expert committee (IEC) may be a great way to improve the quality and homogeneity of clinical trial endpoint results but may lose part of its benefits if it is done slowly and inconsistently. Cloud-based platforms may be the right solution to unleash the full potential of EA. 

Whether requested by regulatory authorities or chosen by a trial sponsor to strengthen the quality of trial endpoints, endpoint adjudication (EA) is undeniably adding complexity to the planning and execution of a clinical trial. If that complexity is not managed with the proper tools it can translate into additional time and cost but this should not be a fatality.

There are three levels of action in regard to a patient crossing the gate of an investigational site: 

First level: Take care of the patient.

No investigator will run to consult the trial protocol when receiving a patient with a suspected cardiovascular event. Let alone if the treating physician is not an investigator at all. Even when filling in the paperwork, physicians think in terms of reimbursement codes rather than study criteria. 

Second level: The trial case report form (CRF).

Here the investigator will report his findings but may face a dilemma if the trial criteria are specific creating a discrepancy between the patient records and the CRF reporting. 

Third level: Endpoint adjudication by the Clinical Endpoint Committee (CEC).

This gives the opportunity to apply strictly the trial criteria in a uniform way regardless of any action taken in urgency at the site. But it has to be done within reasonable time and not consume unreasonable resources. In some cases, patient enrolment may depend on the assessment. In other cases, such as adaptive design, the next steps are based on results flowing continuously into the study database. It is a race against time.

Ethical eAdjudication is a cloud-based platform connecting in real time investigators, sponsors and adjudicators.
It handles, based on the committee charter rules, role-based access, workload distribution, quality assurance and disagreement resolution. eAdjudication provides a user-friendly interface to study sites that can verify data integrity and may partially automate information capture and a simple, yet powerful interface allowing committee members to visualize information (e.g. DICOM images) and provide assessments. Finally, it provides study managers with a full view of the state of operations and with performance management tools that help early detection of outliers and prompt correction of process flaws. All transient information is encrypted and all actions and data are captured in a full audit trail sealed with cutting edge technology (block chain).

Ethical eAdjudication Software is your best chance to win the race against time without losing the race against budget.

The Complete Manual / Reference Book with all the topics related to the Independent Endpoint Adjudication Committees Management

Endpoint Adjudication Process Overview



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